Shoulder PainFIMAGE-TNCT05800184
Finnish Imaging of Shoulder Trauma
An observational study of Shoulder Pain and Shoulder Injuries, run by University of Helsinki at 4 sites in Finland.
Trial summary
The FIMAGE-Trauma study is an extension of the FIMAGE study and aims to answer the question if rotator cuff tears found on shoulder imaging after a shoulder injury are caused by the index trauma or are rather incidental findings. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain, Shoulder Injuries, Rotator Cuff Tears
- How many people
- 40 participants
- Where
- 4 sitesFinland
- Study dates
- 5 Apr 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects from a population based sample (FIMAGE study participants) who sustain a shoulder injury or sudden onset of significant shoulder symptoms within 2 years after the FIMAGE research visit.
Who may be able to join
- Ambulatory
- Participated in the FIMAGE
- Baseline MRI from FIMAGE study available
Who cannot join
- Contraindications to MRI
- Previous shoulder joint replacement
- Previous rotator cuff surgery
Trial locations and contacts
4 sites in 1 country.
Saara Raatikainen contact
Finland4 sites, 4 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki
Thomas Ibounig, M.D., +358504286223, thomas.ibounig@helsinki.fi
Saara Raatikainen, saara.raatikainen@hus.fi
- Not yet recruiting
Kuopio University Hospital
Kuopio
Thomas Ibounig
Saara Raatikainen
- Not yet recruiting
Tampere University Hospital
Tampere, 33520
Thomas Ibounig
Saara Raatikainen
- Not yet recruiting
Turku University Hospital
Turku
Thomas Ibounig
Saara Raatikainen
About this study
The FIMAGE-Trauma study is an extension of the FIMAGE study and aims to answer the question if rotator cuff tears found on shoulder imaging after a shoulder injury are caused by the index trauma or are rather incidental findings. Eligible participants of the FIMAGE study will be invited to a follow up visit in the case of a shoulder injury or a sudden onset of significant shoulder symptoms (within a 2-year time frame). These findings will then be compared to the baseline data collected in the FIMAGE study (including the comparison of pre-injury and post-injury MRI:s)
- Keywords
- Shoulder, Injury, Rotator Cuff, Magnetic resonance Imaging
- Medical subject headings
- Shoulder Pain, Shoulder Injuries, Rotator Cuff Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with a shoulder injury | Individuals from a population based sample of 600 individuals aged 40 to 75 years that sustain a shoulder injury or a sudden onset of significant shoulder symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotator Cuff Integrity on Shoulder Magnetic Resonance Imaging (MRI)
Bilateral shoulder MRI comparing the integrity of the rotator cuff tendons on pre-injury and post-injury MRI scans. Each of the four rotator cuff tendons (supraspinatus, infraspinatus, teres minor, subscapularis) will be assessed and graded for structural changes (normal, tendinopathy, partial thickness tear, full thickness tear). The dimensions of full thickness tears will be measured and recorded (size in millimeters).
Measured: At baseline
Shoulder Pain and Disability Index (SPADI)
Patient reported outcome measure. The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. A SPADI total score ranging from 0 (best) to 100 (worst) is produced by averaging the two subscale scores.
Measured: At baseline
Constant -Murley Score
The Constant-Murley Score was designed to assess the functional state of a shoulder and contains both physician- completed and patient-reported portions. The four domains include pain (15 possible points), activities of daily living (20 possible points), mobility (40 possible points), and strength (25 possible points). Scores range from 0 points (most disability) to 100 points (least disability).
Measured: At baseline
Secondary outcomes (2)
Subjective Shoulder Value (SSV)
The SSV score is defined as the subjective evaluation by the patient of shoulder function, expressed as a percentage of a normal shoulder. This score ranges from 0 to 100%.
Measured: At baseline
Pain NRS
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start5 Apr 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Principal investigator, Professor Teppo Järvinen, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800184
- Sponsor's protocol ID
- HUS/13603/2022
- Acronym
- FIMAGE-T
- Status last verified
- Apr 2023
- First submitted
- 9 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finnish Imaging of Shoulder Trauma
- ClinicalTrials.gov ID
- NCT05800184
- Acronym / sponsor ID
- FIMAGE-T / HUS/13603/2022
- Keywords
- Shoulder, Injury, Rotator Cuff, Magnetic resonance Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Study start
- 5 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The FIMAGE-Trauma study is an extension of the FIMAGE study and aims to answer the question if rotator cuff tears found on shoulder imaging after a shoulder injury are caused by the index trauma or are rather incidental findings. Eligible participants of the FIMAGE study will be invited to a follow up visit in the case of a shoulder injury or a sudden onset of significant shoulder symptoms (within a 2-year time frame). These findings will then be compared to the baseline data collected in the FIMAGE study (including the comparison of pre-injury and post-injury MRI:s)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with a shoulder injury | – | –Individuals from a population based sample of 600 individuals aged 40 to 75 years that sustain a shoulder injury or a sudden onset of significant shoulder symptoms. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects from a population based sample (FIMAGE study participants) who sustain a shoulder injury or sudden onset of significant shoulder symptoms within 2 years after the FIMAGE research visit.
Key inclusion criteria (3 listed)
- Ambulatory
- Participated in the FIMAGE
- Baseline MRI from FIMAGE study available
Key exclusion criteria (3 listed)
- Contraindications to MRI
- Previous shoulder joint replacement
- Previous rotator cuff surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rotator Cuff Integrity on Shoulder Magnetic Resonance Imaging (MRI)
Time frame: At baseline
Bilateral shoulder MRI comparing the integrity of the rotator cuff tendons on pre-injury and post-injury MRI scans. Each of the four rotator cuff tendons (supraspinatus, infraspinatus, teres minor, subscapularis) will be assessed and graded for structural changes (normal, tendinopathy, partial thickness tear, full thickness tear). The dimensions of full thickness tears will be measured and recorded (size in millimeters).
Shoulder Pain and Disability Index (SPADI)
Time frame: At baseline
Patient reported outcome measure. The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. A SPADI total score ranging from 0 (best) to 100 (worst) is produced by averaging the two subscale scores.
Constant -Murley Score
Time frame: At baseline
The Constant-Murley Score was designed to assess the functional state of a shoulder and contains both physician- completed and patient-reported portions. The four domains include pain (15 possible points), activities of daily living (20 possible points), mobility (40 possible points), and strength (25 possible points). Scores range from 0 points (most disability) to 100 points (least disability).
2 secondary outcomes
Subjective Shoulder Value (SSV)
Time frame: At baseline
Pain NRS
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saara Raatikainen contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain and Shoulder Injuries, run by University of Helsinki at 4 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Ibounig, MD (+358504286223, thomas.ibounig@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotator Cuff Integrity on Shoulder Magnetic Resonance Imaging (MRI) (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.